Is this your brand? Sign in to claim ownership.
Sign in to claim this brandNext Orthosurgical
US
Last updated May 23, 2026
What Next Orthosurgical makes
Next Orthosurgical manufactures spinal fixation hardware, including non-bioabsorbable bone screws, internal fixation rods, and polymeric interbody fusion cages for spinal stabilization. Their portfolio also includes vertebral body prostheses, reusable surgical implant templates, and trial implants for spinal procedures. Devices like the InterFuse S and Nex-D2 are designed for internal spinal support and fusion applications.
The company’s products are regulated under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for spinal surgical applications and adhere to U.S. regulatory standards for medical implants.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Next Orthosurgical primarily manufacture?
Next Orthosurgical specializes in spinal fixation devices. Their portfolio includes non-bioabsorbable bone screws, internal spinal fixation rods, polymeric spinal interbody fusion cages, vertebral body prostheses, reusable surgical implant templates, and trial implants for spinal procedures. These devices are designed to support spinal stabilization and fusion during surgical interventions.
Where is Next Orthosurgical based, and how does that affect its regulatory standing?
Next Orthosurgical is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under FDA’s risk-based system (Class I or Class II). This ensures compliance with U.S. medical device standards, though individual devices—not the company—must undergo authorization processes like 510(k) clearance or premarket approval.
Which regulatory registries or databases list Next Orthosurgical’s devices?
Next Orthosurgical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks device details like manufacturer information, model names, and regulatory classifications (e.g., Class I or II) to support transparency and traceability in the U.S. medical device ecosystem.
How are Next Orthosurgical’s devices classified under FDA regulations?
Next Orthosurgical’s devices fall into FDA’s Class I or Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use (e.g., spinal fixation) and potential risks, as outlined in FDA’s regulatory framework.
What does it mean for a Next Orthosurgical device to be listed in the FDA UDI database?
Listing in the FDA UDI database means the device has been assigned a unique identifier (UDI) to distinguish it from others in the market. This helps healthcare providers, regulators, and patients track device history, recall information, and verify compliance with U.S. regulations. The UDI includes details like the manufacturer’s name, device model, and lot number, ensuring transparency in the supply chain.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (5918)
Page 16 of 119| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nex-D2 | CBAPJ-85110 | FDA UDI | Class II | Active |
| Nex-D2 | CBJBK-55055 | FDA UDI | Class II | Active |
| EZ-Track | CAFB402410A | FDA UDI | Class II | Active |
| Nex-D2 | CBFDJ-65050 | FDA UDI | Class II | Active |
| Nex-D2 | CBFBJ-70040 | FDA UDI | Class II | Active |
| Nex-D2 | CBHBJ-55270 | FDA UDI | Class II | Active |
| EZ-Track | CAFB601818H | FDA UDI | Class II | Active |
| Nex-D2 | CBHAD-55315 | FDA UDI | Class II | Active |
| Nex-D2 | CBFBJ-70070 | FDA UDI | Class II | Active |
| Nex-D2 | CBFBJ-70140 | FDA UDI | Class II | Active |
| EZ-Track | CAEZ001012 | FDA UDI | Class I | Active |
| Nex-D2 | CBDBJ-55110 | FDA UDI | Class II | Active |
| Nex-D2 | CBJCD-55115 | FDA UDI | Class II | Active |
| Nex-D2 | CBFCJ-75020 | FDA UDI | Class II | Active |
| Nex-D2 | CBACJ-78085 | FDA UDI | Class II | Active |
| Nex-D2 | CBAJJ-50060 | FDA UDI | Class II | Active |
| Nex-D2 | CBDSD-55080 | FDA UDI | Class II | Active |
| Nex-D2 | CBFAJ-70070 | FDA UDI | Class II | Active |
| Nex-D2 | CBHCJ-55100 | FDA UDI | Class II | Active |
| Nex-D2 | CBFCJ-65050 | FDA UDI | Class II | Active |
| Nex-D2 | CBFDJ-60065 | FDA UDI | Class II | Active |
| Nex-D2 | CBHCK-55155 | FDA UDI | Class II | Active |
| Nex-D2 | CBJCJ-55035 | FDA UDI | Class II | Active |
| Nex-D2 | CBDDJ-55080 | FDA UDI | Class II | Active |
| Nex-D2 | CBECJ-55025 | FDA UDI | Class II | Active |
| Nex-D2 | CBFCJ-78145 | FDA UDI | Class II | Active |
| Nex-D2 | CBAEJ-90100 | FDA UDI | Class II | Active |
| Nex-D2 | CBDJJ-55035 | FDA UDI | Class II | Active |
| Nex-D2 | CBHCJ-55180 | FDA UDI | Class II | Active |
| EZ-Track | CAFB652214H | FDA UDI | Class II | Active |
| EZ-Track | CAFB551811H | FDA UDI | Class II | Active |
| Nex-D2 | CBFBJ-75090 | FDA UDI | Class II | Active |
| Nex-D2 | CBEIJ-55018 | FDA UDI | Class II | Active |
| Nex-D2 | CBFDJ-55125 | FDA UDI | Class II | Active |
| Nex-D2 | CBHCK-55400 | FDA UDI | Class II | Active |
| Nex-D2 | CBJCD-55105 | FDA UDI | Class II | Active |
| Nex-D2 | CBJAJ-55095 | FDA UDI | Class II | Active |
| Nex-D2 | CBARJ-80065 | FDA UDI | Class II | Active |
| EZ-Track | CJBB151310A | FDA UDI | Class II | Active |
| Nex-D2 | CBDKJ-55230 | FDA UDI | Class II | Active |
| Nex-D2 | CBFCJ-75045 | FDA UDI | Class II | Active |
| Nex-D2 | CBFDJ-65085 | FDA UDI | Class II | Active |
| EZ-Track | CAAB261307F | FDA UDI | Class II | Active |
| Nex-D2 | CBHAD-55115 | FDA UDI | Class II | Active |
| Nex-D2 | CBFBJ-78105 | FDA UDI | Class II | Active |
| Nex-D2 | CBHBJ-55470 | FDA UDI | Class II | Active |
| Nex-D2 | CBDMD-55220 | FDA UDI | Class II | Active |
| EZ-Track | CAFB402010A | FDA UDI | Class II | Active |
| EZ-Track | CAFB651817H | FDA UDI | Class II | Active |
| EZ-Track | CAAB240907F | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.